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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05852938




Registration number
NCT05852938
Ethics application status
Date submitted
2/05/2023
Date registered
10/05/2023
Date last updated
4/06/2025

Titles & IDs
Public title
A Study of Zigakibart in Adults With IgA Nephropathy
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Secondary ID [1] 0 0
CHK02-02
Secondary ID [2] 0 0
CFUB523A12301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy 0 0
Immunoglobulin A Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BION-1301
Treatment: Drugs - Placebo

Experimental: BION-1301 - 600mg subcutaneous administration every 2 weeks for 104 weeks

Placebo comparator: Placebo - subcutaneous administration every 2 weeks for 104 weeks


Treatment: Drugs: BION-1301
BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.

Treatment: Drugs: Placebo
Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in proteinuria (natural log UPCR)
Assessment method [1] 0 0
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 40.
Timepoint [1] 0 0
40 weeks or approximately 9 months
Secondary outcome [1] 0 0
Annualized rate of change in eGFR
Assessment method [1] 0 0
Annualized eGFR slope estimated over 104 weeks using the CKD-EPI 2021 creatinine equation
Timepoint [1] 0 0
104 weeks or approximately 2 years
Secondary outcome [2] 0 0
Change from baseline in eGFR
Assessment method [2] 0 0
Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation
Timepoint [2] 0 0
104 weeks or approximately 2 years
Secondary outcome [3] 0 0
Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)
Assessment method [3] 0 0
Percent of participants meeting the composite endpoint of experiencing at least 1 of the following during the study: * At least 30% reduction in eGFR sustained for at least 30 days * eGFR \< 15 mL/min/1.73m\^2, sustained for at least 30 days * Chronic dialysis, = 30 days * Kidney transplantation * All-cause mortality
Timepoint [3] 0 0
Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
Secondary outcome [4] 0 0
Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)
Assessment method [4] 0 0
Percent of participants meeting the composite endpoint of experiencing at least 1 of the following during the study: * At least 40% reduction in eGFR sustained for at least 30 days * eGFR \< 15 mL/min/1.73m\^2, sustained for at least 30 days * Chronic dialysis, = 30 days * Kidney transplantation * All-cause mortality
Timepoint [4] 0 0
Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
Secondary outcome [5] 0 0
Percent Change in Proteinuria and Total Urine Protein
Assessment method [5] 0 0
Percent of participants achieving reduction of proteinuria to \< 1.0 g/day at Week 40 and a = 25% decrease in total urine protein from Baseline
Timepoint [5] 0 0
40 weeks or approximately 9 months

Eligibility
Key inclusion criteria
* Male and female participants aged = 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
* Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
* eGFR = 30 mL/min/1.73m^2 at Screening based on the 2021 CKD-EPI equation.
* Total urine protein = 1.0 g/day or UPCR = 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
* Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.
* Screening weight of 45 to 150 kg.
* Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group [CTFG] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated > 1 month prior to first dose of study drug.
* Provide written informed consent and be willing to comply with study visits and procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
* Diagnosis of IgA Vasculitis.
* Current or history of nephrotic syndrome.
* Average blood pressure > 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated once within the Screening period if clinically appropriate as per the Investigator.
* Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines
* Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN.
* History of Type 1 Diabetes.
* Participants with Type 2 diabetes are excluded if any of the following are present:

* Screening HbA1c (glycated hemoglobin) of > 8%.
* Evidence of diabetic changes on kidney biopsy, performed for any reason.
* History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy) and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular disease, cerebrovascular disease).
* Unstable anti-diabetic regimen:
* Prior exposure to any therapy directed against APRIL.
* History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis, including a history of allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody.
* Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening.
* Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for > 14 days within 12 weeks prior to Screening.
* Use of systemic immunosuppressant medications.
* Any confirmed or suspected immunosuppressive or immune-deficient state, including but not limited to common variable immunodeficiency (CVID), HIV infection or asplenia, history of bone marrow or organ transplantation with exception of corneal transplants.
* Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator.
* Positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody be allowed), or antibodies to HIV-1 and/or HIV-2 at Screening.
* Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug.
* History of malignancy unless cancer free for at least 5 years or non-melanoma skin cancer that was completely resected. A participant with curatively treated cervical carcinoma in situ is eligible for the study. Participants with low-risk prostate cancer (i.e., Gleason score < 7 and prostate specific antigen < 10 ng/mL) are allowed.
* Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
* History or evidence of any other clinically significant disorder, condition, disease, or laboratory finding that, in the Investigator's assessment, would place the participant at unacceptable risk, limit compliance with study requirements, or confound interpretation of study results.
* IgG levels < 6 g/L at Screening.
* Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/06/2028
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Gosford
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [3] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [4] 0 0
Novartis Investigative Site - Penrith
Recruitment hospital [5] 0 0
Novartis Investigative Site - St Leonards
Recruitment hospital [6] 0 0
Novartis Investigative Site - Cairns North
Recruitment hospital [7] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [8] 0 0
Novartis Investigative Site - St Albans
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2750 - Penrith
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
4870 - Cairns North
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3021 - St Albans
Recruitment outside Australia
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United States of America
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Alabama
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California
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Catamarca
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Argentina
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Ciudad Autónoma de BuenosAires
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Belgium
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Antwerpen
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Liège
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Essen
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Ioannina
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India
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Andhra Pradesh
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India
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Haryana
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India
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Karnataka
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India
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Kerala
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India
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Rajasthan
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India
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Tamil Nadu
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India
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Uttar Pradesh
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India
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West Bengal
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India
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Chandigarh
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India
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Dehradun
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Israel
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HaDarom
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Israel
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Tel-Aviv
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Israel
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Be'er Ya'akov
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Israel
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Ramat Gan
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lombardia
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Italy
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Puglia
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Japan
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Aiti
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Japan
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Hokkaidô
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Japan
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Hukuoka
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Japan
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Kanagawa
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Japan
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Nara
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Japan
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Osaka
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Japan
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Tiba
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Tokyo
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Chiba
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Niigata
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Japan
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Okayama
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Japan
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Ôita
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Cheonan
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Seoul
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Malaysia
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Pahang
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Malaysia
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Sarawak
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Malaysia
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Selangor
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Malaysia
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WilayahPersekutuan KualaLumpur
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Mexico
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Chiapas
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Mexico
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Distrito Federal
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Mexico
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Monterrey
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Spain
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Valencia
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Lleida
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Changhua County
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Taiwan
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Hsinchu City
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Taiwan
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Hualien City
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Taiwan
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Kaohsiung
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Taiwan
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Keelung
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei city
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Antalya
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Turkey
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Kayseri
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United Kingdom
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Bristol, City of
Country [138] 0 0
United Kingdom
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East Sussex
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United Kingdom
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Lancashire
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United Kingdom
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Leicestershire
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United Kingdom
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London, City of
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Nottinghamshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05852938